Bioray Biotech Achieves New Milestone: Allogeneic Universal CAR-T Therapy BRL-301 Receives IND Approval for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Screenshot of CDE Approval

B-cell Non-Hodgkin Lymphoma（B-NHL）Is a group of malignant tumors derived from B lymphocytes, occurring in lymph nodes and/or extranodal lymphoid tissues, with significant heterogeneity, accounting for non-Hodgkin lymphoma.（NHL）75-93%. Large B-cell lymphomas, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and transformed follicular lymphoma, are treated with combination chemo-immunotherapy after a confirmed diagnosis. 60% of advanced-stage patients may receive R-CHOP.(such as Rituximab, Cyclophosphamide, Doxorubicin, etc.)Patients who fail R-CHOP treatment in immunochemotherapy regimens generally have a poor prognosis, especially those with relapsed/refractory conditions, whose prognosis is extremely poor. In addition to traditional immunochemotherapy, targeted therapies and autologous CAR-T cell therapy show limited response rates in patients with R/R B-NHL and pose challenges such as long treatment cycles, significant toxic side effects, and high costs. Therefore, there is an urgent need for safer and more accessible innovative therapies for cancer patients who cannot tolerate high-intensity treatments or have poor-quality autologous T cells.

BRL-301 is based on the globally leading universal cell platform TyUCell.^®, by the founder & chairman of BRL Medicine, East China Normal UniversityLiu MingyaoProfessor andDu BingThe scientific team led by the professor has developed a brand-new generation of allogeneic universal CAR-T technology after 8 years of research and multiple technical iterations since 2016.Mainly achieve immune escape and functional optimization of allogeneic T cells through multiple gene editing technologies, avoiding graft-versus-host disease from the source.（GVHD）Host Rejection（HVG）The risk has been perfectly overcome, breaking through the most critical technical barrier in the development of allogeneic universal CAR-T products: the rejection of allogeneic cells by the patient's immune system. On the basis of ensuring the safety and efficacy of cellular products, it truly realizes the generalization of immune cell therapy products. The approval of this expanded indication further validates the potential of this UCAR-T technology in multi-indication development.

It can be said that, compared with similar products at home and abroad,BRL-301 UCAR-T Therapy Has Three Core Advantages:

BRL-301, as an "off-the-shelf" universal CAR-T product, eliminates the need for patient autologous cell collection and customized production. A single batch can meet the treatment needs of over 200 patients, significantly reducing production costs and markedly shorteningCompletedPatient waiting time. No needThe characteristics of HLA matching are particularly suitable for R/R B-NHL patients with rapid disease progression or impaired autologous cell function, providing a "timely rain" treatment option for those who have failed traditional therapies.

BRL-301 does not require additional lymphodepletion or immunosuppression for patients. By using conventional or even lower lymphodepletion regimens, it can achieve complete tumor cell clearance while effectively avoiding risks such as infections, neutropenia, and slow lymphocyte recovery caused by excessive immunosuppression. Early clinical trial data shows that no patients experienced cytokine release syndrome of grade 3 or higher.（CRS）Or Neurotoxicity（ICANS）, the infection rate is lower than that of similar products, demonstrating its excellent clinical safety.

BRL Medicine Selects Healthy DonorsT cells and optimize the expansion process, enabling BRL-301 to possess stronger proliferation capabilities and long-term persistence in vivo. In the early-stage clinical trial research of the product,BRL-301 has alreadyDemonstrated significant and lasting tumor clearance capabilities, with all tested tumor patients achieving complete remission.(CR or CRi), showing significant proliferation and long-term persistence in patients, bringing the possibility of long-term survival.

Professor Liu Mingyao

Founder & Chairman of BRL Medicine

"BRL-301 in the Field of Hematological Tumors TargetsRelapsed/Refractory B-Cell Acute Lymphoblastic Leukemia（R/R B-ALL）AndRelapsed/Refractory B-cell Non-Hodgkin Lymphoma（R/R B-NHL）The rapid advancement of dual indications demonstrates the significant advantages of BRL Medicine's next-generation allogeneic universal CAR-T in addressing industry pain points. Additionally, our breakthrough based on this UCAR-T technology in the treatment of autoimmune diseases marks the world's first revolutionary progress of its kind. Moving forward, we will actively promote the transformation and application of this technological product to benefit a wide range of patients."

Currently, BRL Medicine is advancing the multi-center clinical trials of BRL-301 in China and actively exploring the application of allogeneic universal UCAR-T technology in hematologic tumors, solid tumors, and autoimmune diseases. It can be said that this IND approval not only benefits patients with relapsed or refractory lymphoma...（R/R B-NHL）The patient has opened a new channel for life, and this will also push China's innovative cell therapy technology to an internationally leading position.